At Fisher BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside. Fisher BioServices is a brand of Thermo Fisher Scientific, the world leader in serving science, and member of the BioPharma Services Division. To learn more please visit www.fisherbioservices.com
We are the world's leading provider of biological sample, clinical material management, and cell therapy logistics services. We provide customized solutions for specimen kit assembly and collection, cold-chain transport, lab processing, biobanking and repository services that ensure our customers’ success and peace of mind. Extending to the entire spectrum of cell-based and regenerative medicine worldwide, Fisher BioServices also provides distribution of cell-based therapies from manufacturer to patient bedside, with complete chain of custody documentation.
The Leader in Critical Biological Material Management
We are the specialists in safeguarding biological materials, with more than 28 years of experience in providing superior stewardship of irreplaceable biospecimens, active pharmaceutical ingredient, cell lines, vaccines, and other biological materials and associated data under title 21 part 11 compliance. We offer a global infrastructure and specialized expertise with cryogenic and other specialized storage and distribution challenges for regenerative medicine and cell-based therapies.
We are the pioneer in cell therapy, assisting in exciting studies and Phase 3 in cell therapy. The validation lead engineer allows for exploration of this is a new and exciting field and an opportunity to learn more about commercialization, clinical phases, and testing. If you have experience in cleaning validation, temperature, controlled environments, testing and are ready to join an innovative and expanding organization this role is for you.
The Validation Lead Engineer will handle the day-to-day operations of the Validation Team. Duties include but are not limited to: supervising/training of validation personnel; prioritizing/coordinating validation/calibration efforts; assisting in the development/execution of equipment, process, and shipper qualification activities; assisting QA in client audits; assisting S&M in promoting our services; training operations personnel, as needed; developing equipment qualification templates; assisting the validation manager in performing annual reviews and preparing annual budgets; implementing a Technical Training Program.
- Prioritize and coordinate the daily activities of the Validation Engineers and Technicians/Validation contractors.
- Develop validation protocols to support the qualification/validation of equipment, processes and facilities (e.g.IQ, OQ and PQ protocols, Operational SOPs Change Controls, User/Functional/Design Specifications, etc).
- Coordinate & execute equipment qualification protocols and accurately document results of the defined testing, comparing and reporting those results to predefined/approved acceptance criteria.
- Generate and execute all Validation protocols (IQ/OQ/PQ) of all site equipment including production equipment, utilities as applicable) and other related systems in a FDA regulated environment.
- Organize and present validation and qualification data, results, documentation and reports within the appropriate equipment/system validation files.
- Initiate and execute Corrective and Preventative Actions (CAPA) as required and / or contributing to/supporting CAPAs as needed to resolve deviations resulting from qualification studies
- Update and maintain Validation Master Plans, Validation Plans, Validation Protocols, Qualification Program SOPs, forms, records to meet cGMPs and federal regulatory requirements.
- Ensure timely test completion and result reporting.
- Ensure appropriate staff appointment and training.
- Implement improvement projects to drive increased flexibility and reduce costs.
- Experience/understanding of ICH Q9 Quality Risk Management is desired.
- Knowledge of conducting temperature mapping studies, including the operation of Kaye Data loggers or equivalent preferred.
- Preparation of project plans, budgets and special assignments. Develop and implements strategic and tactical plans to accomplish business objectives; prepares project budgets and manages to plan.
- Author procedures, investigations, protocols, change controls, etc. to support the Maintenance and Engineering departments.
- Requires ability to communicate effectively verbally and in written form.
- Ability to prepare reports using Excel; knowledge of Windows, Word and Access preferred.
- Knowledge of universal Precautions, general laboratory and quality assurance/control preferred.
- Valid driver’s license and good driving record if required to travel to other locations.
- Bachelor of Science Degree with a minimum of 5 years related work experience including a minimum of 2-5 years of supervisory experience. Advanced degree strongly preferred.
- Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
- A very strong working knowledge of regulatory requirements and ISO requirements in the parenteral pharmaceutical industry.
- Excellent verbal and written communication skills required
- Experience with and knowledge of related quality systems such as Change Control; CAPA (including Deviations/OOSs); Training; and Document Control is required.
- Experience with validation aspects of facility start-up, redesign/retrofit, and expansion is desired.
- Ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents, marked changes in temperature.
- Must use personal protective equipment and adhere to safety protocols.
- Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
- Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C) for up to 6 hours per day.
- Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hours per day.